Design & Testing Considerations

Material selection is crucial when designing for your sterile barrier system. Our experts can help you identify the appropriate material for your unique application. 

Consider the following when selecting your sterile barrier system materials: sterilization method; device profile; necessary barrier properties: uv, oxygen, or microbial biocompatibility; labeling options; aging and shelf life; and aseptic presentation.

There are countless factors to consider for the successful design and aseptic presentation of your sterile barrier system. With decades of expertise, our packaging experts help you get it right the first time. 

Some factors to consider: environmental considerations, user requirements, device profile, shelf life, sterilization method, distribution and climate conditions, packaging equipment, and aseptic presentation.

Although Oliver doesn’t conduct performance or stability testing, our experts use industry best practices and ASTM standards to design your packaging to pass testing the first time.

Performance testing: vibration and drop testing, compression testing, climate conditioning, concentrated impact testing, bridge impact testing, and altitude testing 

Stability testing: aging testing

Integrity testing: dye penetration testing, and bubble leak testing

Seal strength testing: peel test and seal width measurement

Making sure you have a repeatable and reproduceable sealing process is key to meeting ISO 11607 Part 2. Let our experts help you navigate the challenges of sealing validation for expedited results.

Installation Qualification (IQ): Verifies the equipment is installed according to the equipment manual and manufacturers specifications. Including wiring, safety features, and utilities.

Operational Qualification (OQ): Determines the upper and lower manufacturing operating parameters limits that creates a continuous seal that forms a sterile barrier system. This includes verifying the process achieves seal specifications without defects.

Performance Qualification (PQ): Demonstrates a repeatable and reproduceable process under nominal operating conditions as set in the OQ.